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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelens, multifocal intraocular
Generic Namelens, multifocal intraocular
Regulation Number886.3600
Alcon Research, Ltd.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP040020
Supplement NumberS014
Date Received03/09/2009
Decision Date08/20/2009
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Clinical Trials NCT00684138
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling,revising the directions for use (dfu) and patient brochure with updated six-monthfollow up data from the clinical investigation for the lenses. The devices, as modifiedwill be marketed under the trade name acrysof iq restor intraocular lenses(iols) +3. 0 d (models: sn6ad1 and mn6ad1) and +4. 0 d (models: sn6ad3 andmn6ad3) add powers and is indicated for primary implantation for the visual correctionof aphakia secondary to removal of a cataractous lens in adult patients with or withoutpresbyopia, who desire near, intermediate and distance vision with increased spectacleindependence. The lens is intended to be placed in the capsular bag.